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Anti-tumor antibiotic
Pembrolizumab + Chemotherapy for Thyroid and Salivary Gland Cancer (iPRIME Trial)
Phase 2
Recruiting
Led By Tanguy Seiwert
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically confirmed disease that is unresectable and not amenable to curative intent therapy
Cohort A: salivary gland cancers (mucoepidermoid carcinoma, adenocarcinoma, adenoidcystic carcinoma, acinic cell carcinoma, or other histology) originating in salivary glands
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment until the first record of death by any cause, up to 100 months, whichever comes first.
Awards & highlights
iPRIME Trial Summary
This trial is testing a new cancer treatment that combines two agents.
Who is the study for?
Adults with certain types of thyroid or salivary gland tumors that can't be removed by surgery or treated with curative intent. Participants must have a life expectancy over 12 weeks, good performance status, and acceptable organ function. Women of childbearing potential and men must agree to use contraception. Exclusions include recent participation in other trials, known allergies to trial drugs, active infections like TB or hepatitis, significant heart disease, autoimmune diseases requiring treatment within the past 2 years, untreated brain metastases, pregnancy/breastfeeding.Check my eligibility
What is being tested?
This Phase II trial tests Pembrolizumab (200mg IV every three weeks) combined with Docetaxel (75mg/m2 IV every three weeks) on patients with specific thyroid and salivary gland cancers. It's a single-arm study where all participants receive the same treatment regimen.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions such as inflammation in various organs; infusion-related symptoms; fatigue; blood cell count changes leading to increased infection risk; allergic reactions to medication components; and possible harm to an unborn baby.
iPRIME Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My disease cannot be surgically removed and cannot be cured with treatment.
Select...
I have a type of salivary gland cancer.
Select...
My thyroid cancer is resistant to radioiodine and hasn't responded well to certain therapies, or it's aggressive.
Select...
I am fully active or can carry out light work.
Select...
I am 18 years old or older.
iPRIME Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of treatment until the first record of death by any cause, up to 100 months, whichever comes first.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment until the first record of death by any cause, up to 100 months, whichever comes first.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of response
Secondary outcome measures
Number of adverse events
Overall rate of survival
Rate of progression free survival
Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
iPRIME Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: 'aggressive' thyroid cancer without SOC treatment opExperimental Treatment2 Interventions
All patients will receive pembrolizumab and docetaxel. First pembrolizumab and docetaxel will be given together. After which patients will receive pembrolizumab alone until disease progression or up to 35 cycles (about 2 years).
Group II: Cohort 1: salivary gland tumors without SOC treatment optionExperimental Treatment2 Interventions
All patients will receive pembrolizumab and docetaxel. First pembrolizumab and docetaxel will be given together. After which patients will receive pembrolizumab alone until disease progression or up to 35 cycles (about 2 years).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,008 Previous Clinical Trials
822,205 Total Patients Enrolled
Tanguy SeiwertPrincipal InvestigatorUniversity of Chicago
6 Previous Clinical Trials
1,061 Total Patients Enrolled
Alexander PearsonPrincipal InvestigatorUniversity of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for more than 12 weeks.I have a history of lung inflammation not caused by infection.I have not taken high doses of steroids or immunosuppressants in the last week.I have an active tuberculosis infection.I have another cancer, but it's either being treated, not growing, or won't affect my life expectancy within 3 years.I have a type of salivary gland cancer.My thyroid cancer is resistant to radioiodine and hasn't responded well to certain therapies, or it's aggressive.My cancer can be measured by scans, or I have cancer that has spread to bones (with special approval).I can provide tissue samples for PD-L1 testing, with at least 10 slides.My organ functions are within normal ranges as required.I agree to use or continue using birth control for 120 days after my last treatment dose.I am using two birth control methods or am not having sex to join this study.I agree to have a biopsy if my tumor can be safely accessed.I have active brain metastases or cancer in the lining of my brain but have been stable for 4 weeks after treatment.I haven't needed strong medication for an autoimmune disease in the last 2 years.I have not received a live vaccine in the last 30 days.I am allergic to pembrolizumab, docetaxel, or their ingredients.I haven't had cancer treatment with antibodies or targeted drugs in the last 3 weeks.I have had an organ transplant and take drugs to suppress my immune system.My disease cannot be surgically removed and cannot be cured with treatment.I do not have serious heart conditions like recent heart attacks or severe heart failure.I am fully active or can carry out light work.I am 18 years old or older.You have active Hepatitis B or Hepatitis C.I have recovered from side effects of my last cancer treatment.You have HIV, but if your CD4 count has been stable at over 200 for at least 6 months, you can still join the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: salivary gland tumors without SOC treatment option
- Group 2: Cohort 2: 'aggressive' thyroid cancer without SOC treatment op
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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